Supervisor - Product Surveillance

Date: Jul 20, 2024

Location: Naples, FL, US, 34108

Company: Arthrex

 Requisition ID:                       60325                         
Title: Supervisor - Product Surveillance
Division: Arthrex, Inc. (US01)
Location: Naples, FL

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Supervisor, Product Surveillance who will develop, lead, and engage a staff of Product Surveillance Specialists and / or Product Surveillance professionals who are responsible for receiving, processing, analyzing, and monitoring of product complaint issues in accordance with the requirements of 21 CFR 820, ISO 13485:2016, as well as international medical device standards.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities:

  • Supervise and lead the activities of the Arthrex, Inc. Product Surveillance Specialists and /or Product Surveillance professionals as assigned by the Product Surveillance Manager.
  • Oversee the coordination of global Field Event activities among the Arthrex Inc. sites.
  • Motivate and empower the team to initiate and engage in continuous improvement activities.
  • Manage the product recall, complaint intake, and emerging issues processes; others as assigned.
  • Oversee the coordination of field corrective actions between Arthrex and the FDA and other international regulatory agencies.
  • Foster a team environment where individuals work together to help each other with problem solving, workflow issues, and overcoming barriers to success.
  • Drive improvements to the Quality Management System and software as related to complaints and product / field corrective actions.
  • Assign projects, schedule work assignments, and train new employees.
  • Provide performance evaluations, team building, and disciplinary action when necessary.
  • Meet departmental process efficiency goals for all product complaints from receipt to closure.
  • Contribute to various department functions during times of short staff.
  • Assure that systems and personnel keep pace with new requirements, techniques, workflows, and increased volume.
  • Research and resolve business transaction conflicts.
  • Maintain a current knowledge of regulations affecting the department.
  • Provide status reports related to quality and efficiency goals.
  • Participate in FDA, MDSAP, and international 3rd party audits and inspections as a department representative.

 

 

Education and Experience:

  • Bachelor’s degree in engineering, science, regulatory compliance, or related areas required. Master’s degree is preferred.
  • 5 years progressive experience in medical device complaint management in an FDA /ISO regulated environment.
  • 10 years’ experience within a Medical Device QA function(s).
  • Personnel team leadership experience preferred.

 

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Working knowledge of ISO, FDA, MDD /MDR and international medical device / drug quality requirements. 

Excellent customer service skills required.

Demonstrated leadership qualities required– Leading by example, meeting challenges in a positive way, and a proactive, strategic mind-set.

 

Machine, Tools, and/or Equipment Skills:

Proficiency in Microsoft Office applications is required.

Knowledge of Pilgrim Smart Solve, Salesforce, SAP and /or Agile is a plus.

 

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

 

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

 

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

 

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

Specific vision abilities required by this job include close vision.

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.

Arthrex Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

 

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.


Nearest Major Market: Naples

Job Segment: Medical Device, Manager, QA, ERP, Quality Assurance, Healthcare, Management, Quality, Technology